UH3 Project: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction)
Overview
Principal Investigators:
Sponsoring Institution: Kaiser Foundation Research Institute, Seattle WA (Performance Site)
Collaborators:
- Kaiser Permanente Department of Research, Oakland, CA (Performance Site)
- Sutter Health Research Institute, Palo Alto, CA (Performance Site)
- Institute of Family Health, New York City, NY (Performance Site)
- RAND Corporation, Santa Monica, CA
NIH Institute Providing Oversight: National Center for Complementary and Integrative Health (NCCIH)
Program Official: Lanay Mudd, PhD (NCCIH)
Project Scientists: Basil Eldadah, MD, MPH (National Institute on Aging [NIA])
ClinicalTrials.gov Identifier: NCT04982315
Trial Status: Enrolling
Trial Summary
A critical gap exists in evidence regarding the safety and effectiveness of treatments for older adults with chronic low back pain (cLBP). Acupuncture has been found to be effective in treating cLBP in younger adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently than typical trial participants. BackInAction is a pragmatic randomized trial designed to address this gap.
After a planning year to refine strategies to identify and recruit patients, finalize acupuncture protocols with an acupuncture advisory panel, and ensure data infrastructure and quality, the study team will conduct a three-arm trial of 789 adults ≥65 years of age with cLBP to evaluate acupuncture versus usual care. The study will compare a standard 3-month course of acupuncture with an enhanced course of acupuncture (3-month standard course, plus 3-month maintenance course) to usual medical care for cLBP. The primary outcomes of this large trial will be back-related function at 6 months. These and other biopsychosocial measures will be collected at 3, 6, and 12 months post-randomization. The expectation is that back-related function in older adults with cLBP will be most improved among participants in the enhanced acupuncture arm, followed by the standard acupuncture arm, and least improved among those receiving only usual care.
Medicare is also interested in additional data on the value of acupuncture for older adults as they implement their coverage decision. As such, to supplement knowledge gained from the effectiveness trial, the study team may conduct a cost-effectiveness analysis of both forms of acupuncture compared with usual care.
The large study sample will be recruited from four diverse health plans to represent the ethnic and racial composition of Medicare enrollees as well as the most common ways acupuncture is incorporated in insurance-based care for chronic pain. If successful, this pragmatic RCT will offer clear guidance about the value of acupuncture for improving functional status and reducing pain intensity and pain interference for older adults with cLBP. This evidence will provide important information for Medicare about the value of acupuncture in their beneficiaries and for individual physicians and patients deciding on a course of treatment.
Data and Resource Sharing
- BackInAction-2021-UH3 Follow-up
BackInAction-Ethics and Regulatory UH3 Follow-up
- AcuOA UG3 Minutes and Supplement_C
AcuOA (BackInAction) Ethics and Regulatory Discussion
Featured Interviews
Drs. DeBar and Sherman discuss the BackInAction (formerly AcuOA) NIH Collaboratory Trial.
News and Interviews
- News_Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record
January 8, 2024: Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record
- News_A Year of New Insights From the NIH Pragmatic Trials Collaboratory
December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory
- News_Biostatistics Core Develops Tools and Strategies for Common Research Challenges
August 16, 2022: Biostatistics Core Develops Tools and Strategies for Common Research Challenges
- News_BackInAction Is Back on Track After COVID-19 Delays
June 30, 2022: BackInAction Is Back on Track After COVID-19 Delays
- News_A Year of New Insights From the NIH Collaboratory
December 14, 2021: A Year of New Insights From the NIH Collaboratory
- News_Study Snapshots for PRISM Projects
January 11, 2021: Study Snapshots for Four PRISM UH3 Trials Are Available
- News_PRISM_Continuation
October 6, 2020: Four PRISM Trials Awarded Continuation from Planning to Implementation Phase
- Drs. Karen Sherman and Lynn DeBar Introduce the AcuOA Demonstration Project
Drs. Karen Sherman and Lynn DeBar Introduce the AcuOA (now BackInAction) Trial
- News_AcuOA to Inform Medicare Coverage Decisions on Acupuncture
March 9, 2020: BackInAction (formerly AcuOA): An Interview With Dr. Karen Sherman and Dr. Lynn Debar
Products and Publications
- DeBar et al Contemp Clin Trials 2023
BackInAction Study Design Paper
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Nielsen et al Glob Adv Health Med 2021
Acupuncture intervention protocol: consensus process for a pragmatic randomized controlled trial of acupuncture for management of chronic low back pain in older adults: an NIH Heal Initiative funded project
- BackInAction Study Snapshot
BackInAction Study Snapshot
- Living Textbook Chapter_Which PCTs Should Have a DMC
Living Textbook Chapter: Which PCTs Should Have a DMC?
- Living Textbook_How Are PRO Measures Used
Living Textbook: How are PRO Measures Used?
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
Presentations
- HEAL US Pain Foundation CA presentation DeBar 13Sep2023_final
Evaluating Acupuncture for Older Adults with Chronic Low Back Pain in a Pragmatic Fashion: the Back In Action study
- IFH Response&Success_Symposium poster 24May2023
IFH: Response and Success As Partner in Multi-Site NIH Acupuncture Research Study
- DCTR_SCT_overall_final Walter_21May2023
Improving Racial and Ethnic Diversity in Clinical Trials
- SAR_BIAPresentation_2023_Eng_18May2023_final
Lessons Learned from the BackInAction Pragmatic Trial of Acupuncture Among Older Adults: Unique Challenges and Opportunities at a New York City FQHC
- Consortium_InnovationIntegrationfinal Teets 28Feb2023
Innovation & Integration in Acupuncture Research in the Underserved: Embedding Research in an FQHC
- Poster_HCSRN_Feb2023_BIA_v8_F1 Sanchez 21Feb2023
“Who Says Older Folks Aren’t Tech-Savvy? Experience with a Fully Electronic Consent Procedure in a Trial with Older Adults”
- Poster_HCSRN_Feb2023_BIA_v8_F1
Who Says Older Folks Aren’t Tech-Savvy? Experience with a Fully Electronic Consent Procedure in a Trial with Older Adults
- 2023 HCSRN Poster_BackInAction_Final
Recruiting for a multisite pragmatic clinical trial during COVID-19
- SC-Mtg-2023-Day2-DeBar-Back in Action
Lynn DeBar Back in Action Presentation 2023 Steering Committee Meeting
- International Congress on INtegrative Medicine and Health_Nielsen poster
Collecting Treatment Data Efficiently in Large Trials of Acupuncture: STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) meets Technology
- International Forum on Back and Neck Pain Research in Primary Care_Sherman
Pragmatic trial of acupuncture for chronic low back pain (cLBP) in older adults
- AcuOA_Sherman_DeBar_PRISM Kickoff_FINAL1
BackInAction (formerly AcuOA) Presentation at the PRISM Kickoff Meetings